How One Pill Escaped Place on Steroid List

By ANNE E. KORNBLUT and DUFF WILSON

ASHINGTON, April 15 - On the shelves of health stores across the country sits a dietary supplement that advertisements boast can "significantly alter body composition" - by converting to steroids in the bloodstream and, for some, helping pump up muscles as traditional steroids do.

But unlike every other substance in the steroid family, the supplement, DHEA, is not classified as a controlled drug. In fact, the chalky white pills and capsules enjoy an exemption under federal law, thanks to a bill passed by Congress late last year.

How DHEA, or dehydroepiandrosterone, came to enjoy legal protections granted by Congress - at the very moment that steroid abuse was grabbing national headlines, and just months before Congress itself held hearings on the use of body-building drugs in professional baseball - is a study in skillful political maneuvering, according to participants in the deal.

Sports officials had favored an overall ban on steroids and related pills, like DHEA, which is banned by the Olympics, the World Anti-Doping Agency, the National Collegiate Athletic Association, the National Football League, the National Basketball Association and baseball minor leagues.

Major League Baseball is the exception on banning DHEA, and at last month's Congressional hearings, the top medical adviser to the league turned the tables on lawmakers, accusing them of failing to write zero tolerance toward steroids into federal law. Baseball officials say that the legal loophole has made it harder for them to ban DHEA in their own policy, which is already under fire.

"It is difficult, from a collective bargaining perspective, to explain to people why they should ban a substance that the federal government says you can buy at a nutrition center," said Rob Manfred, executive vice president for labor relations at Major League Baseball.

Nevertheless, Senator Orrin G. Hatch of Utah, a Republican who represents a state where many dietary supplements are produced and who is a longtime champion of herbal remedies, felt strongly last year that DHEA must be kept legal and available as an "anti-aging" pill. Other lawmakers and staff members said he threatened to kill a far-reaching piece of legislation restricting the sale of other steroids, educating children about the dangers of steroids and increasing penalties for illegal use if his colleagues did not agree to include an exemption for DHEA.

His son Scott Hatch is a lobbyist for the National Nutritional Foods Association, a trade association for the dietary supplement industry, and has represented supplement companies themselves, including Twin Laboratories, which sells DHEA. The elder Mr. Hatch said he did not think he had been lobbied by his son, and cited the legitimate uses for DHEA as his reason for fighting for it.

"There is a big argument that DHEA is very beneficial for health and well-being," Mr. Hatch said, noting that he did not believe there was significant opposition to leaving DHEA on the market. "I didn't see much resistance," Mr. Hatch said. "There are always those who are against any dietary supplement or anything not subject to total FDA approval." He was joined in fighting for the exemption by Senator Tom Harkin, Democrat of Iowa, a leading supporter of dietary supplements.

Most DHEA is manufactured in China from the dried roots of wild yam. About $47 million worth was sold in the United States in 2003, the most recent year for which sales figures have been compiled, according to Patrick D. Rea, research director for The Nutrition Business Journal. In humans, where DHEA is produced naturally in the adrenal glands, levels of the hormone usually peak by age 25. The synthetic version is primarily marketed as an anti-aging drug.

The F.D.A. banned over-the-counter sales of DHEA in 1985. It reappeared after Congress passed the Dietary Supplement Health and Education Act of 1994, releasing a flood of supplements classified as foods rather than drugs, and not requiring the F.D.A.'s approval. Senators Hatch and Harkin also led the push for that bill.

Although DHEA advocates say the supplement has a good safety record, there have been only limited studies of its performance and side effects. Its promised benefits, including enhanced mental acuity and slowed aging, have not been proven conclusively, and some scientists say there is still concern it could accelerate cancers.

"There isn't any logical reason it should be exempt," said Sidney Wolfe, director of the Health Research Group at Public Citizen, a consumer advocacy organization.

Utah is a nexus for vitamin and supplement production and distribution. Loren D. Israelsen, executive director of the Utah Natural Products Alliance, said the industry started with four successful companies there and grew to more than a hundred. "Success begets success," Mr.Israelsen said.

Senator Hatch and his son have a history of fighting for herbal remedies. The elder Hatch has played a leading role on two Senate committees that have oversight over the Food and Drug Administration and the Drug Enforcement Agency. Senator Hatch was also author of the landmark legislation limiting the authority of the Food and Drug Administration to oversee supplements.

Senator Hatch has also in the past defended the herbal supplement ephedra, which has been linked with more than 100 deaths. He supported a federal ban of ephedra in April 2004 after the deaths were reported. A federal judge in Salt Lake City overturned the ban last week.

Lawmakers in both parties said the exemption for DHEA was created only in order to secure passage of a broader bill, the Anabolic Steroid Control Act of 2004.

The law, which took effect on Jan. 20, expanded the definition of anabolic steroids to include substances like androstenedione, or andro, which turns into testosterone after it is ingested. Andro was made famous by the former St. Louis Cardinals player Mark McGwire, who admitted taking it around the time of his record-breaking home run season in 1998. Andro and other steroids can enhance muscle growth; if abused, they can cause longterm physical and psychological harm.

As the abuse of steroid-like supplements became more widely discovered, athletic and medical groups pressed for stricter legislation, arguing that any substance that turns into a steroid hormone once it is digested should be regulated by the Drug Enforcement Administration.

But faced with opposition from Mr. Hatch, lawmakers ultimately decided it was not worth sinking the entire bill to ban DHEA, several said. The law, which was passed without objection, gave the Drug Enforcement Administration more power to ban new steroids, with one named exemption, DHEA.

"We had to make a practical decision to get it passed," said Representative John E. Sweeney, Republican of New York.

Representative Henry A. Waxman, Democrat of California, said DHEA was protected "because of the economic pressures from the dietary supplement people that stand to make a lot more money by selling it."

Besides the supplement industry and its select advocates in Congress, Mr. Waxman said: "No one else argued it should be given an exemption. The only opposition came from the supplements industry, and they're making millions off the sale of DHEA supplements."

According to one Congressional aide who worked on writing the legislation, in one particularly intense negotiation with Senator Hatch, the Utah senator's staff members "were adamant that they were not going to take out the exemption."

Other current and former Congressional staff members - all speaking on condition of anonymity because they were not authorized to talk about back-room negotiations - gave similar accounts. One senior aide who helped broker the agreement said: "We had to do an exemption for DHEA not because it was the right thing to do, to be perfectly honest, but because it was the politically necessary thing to do."

Congressional aides said they had not dealt directly with Scott Hatch, the senator's son, but had worked with Jack Martin, a partner in his firm, on this and other supplement issues. Mr. Martin is a former longtime aide to Senator Hatch. They did not return calls for comment.

Senator Hatch, in an interview, defended the DHEA exemption, calling it "basically a good dietary supplement." "Andro is an anabolic steroid precursor, and DHEA is far removed from that, from everything I've read and everything I've studied," he said. In fact, DHEA is a first cousin of andro: in the body, DHEA metabolizes into andro and then into testosterone.

Asked whether his son had lobbied on the exemption, Mr. Hatch replied, "Not that I know of."

"In fact, he won't even talk to me. He is that touchy," Mr. Hatch said. "He works the House and does it very honorably. He's very prissy about it, in fact. He doesn't have to be that prissy about it." He added: "His business is his business, not mine."

With andro now illegal, athletes who want to try to get a steroid effect from a legal pill are now more likely to turn to DHEA, according to Dr. Gary Green of the Olympic Analytical Laboratory at the University of California, Los Angeles. Speaking to high school coaches in Texas about steroids in February, Dr. Green, an adviser to baseball, said coaches should ask why DHEA received an exemption, which member of Congress was responsible for that, what state he was from and what state makes products from DHEA.

But there is no evidence yet, other than chatter on Web sites, that athletes or young people are turning to DHEA as a replacement for traditional steroids and precursors, despite the fears of some medical experts that the trend will begin now that the law banning other substances has taken effect.

Susan Trimbo, a scientist with General Nutrition Centers, one of the nation's largest sellers of DHEA, said the drug has a good safety record, with side effects including acne and some facial hair issues in women. The drug affects women more than men because women naturally produce less testosterone.

"It's a rather weak steroid, so I don't see it as a good substance for abuse, from my perspective," Ms. Trimbo said.

But some advertisements do take aim at athletes, including promotions on the Web sites http://www.teenbodybuilding.com/, http://www.bodybuilding.com/ and http://www.musclesurf.com/.

One advertisement says: "DHEA is HOT, and you will see why. As a pre-cursor hormone, as it leads to the production of other hormones. When this compound is supplemented, it has been shown to have awesome effects."

Another advertisement, from AST Sports Sciences, says: "What Can DHEA Do for Me? If you're a bodybuilder, and want to increase in lean body mass at the expense of body fat, studies show this supplement may significantly alter body composition, favoring lean mass accrual."

There have been few studies of the effects of large doses of DHEA. One, in 1988, found that DHEA decreased body fat and increased muscle mass in five young men given 1,600 milligrams a day for 28 days, compared with five men given placebos.

"Fortunately, reports of serious side effects to date have been minimal," Patricia D. Kroboth, dean at the University of Pittsburgh School of Pharmacy, wrote in a review article in 1999. But Dr. Kroboth noted there have been no large-scale clinical trials gathering information on side effects, concluding, "Until we understand the risks and benefits of DHEA administration, its use in other than an experimental setting is not warranted."